FDA 510(k)

MODELS 54601/54602/54603/54604 NEEDLE & BIOPSY KIT

K-Number: K864329 · 1986-12-03

Decision Date1986-12-03

Product CodeKNW

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

MODELS 54601/54602/54603/54604 NEEDLE & BIOPSY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Dlp, Inc.. It received FDA 510(k) clearance on 1986-12-03 under 510(k) number K864329. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODELS 54601/54602/54603/54604 NEEDLE & BIOPSY KIT?

MODELS 54601/54602/54603/54604 NEEDLE & BIOPSY KIT is a medical device that received FDA 510(k) clearance on 1986-12-03. The listed applicant is Dlp, Inc.. The 510(k) number is K864329.

When did MODELS 54601/54602/54603/54604 NEEDLE & BIOPSY KIT receive FDA 510(k) clearance?

MODELS 54601/54602/54603/54604 NEEDLE & BIOPSY KIT received FDA 510(k) clearance on 1986-12-03, under 510(k) number K864329.

Who is the listed applicant for MODELS 54601/54602/54603/54604 NEEDLE & BIOPSY KIT?

The FDA 510(k) record lists Dlp, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODELS 54601/54602/54603/54604 NEEDLE & BIOPSY KIT?

The FDA product code for MODELS 54601/54602/54603/54604 NEEDLE & BIOPSY KIT is KNW.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Dlp, Inc. as applicant

K973485CLEARVIEW BLOWER/MISTER K964445OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006)K953945RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF & INTRODUCER STYLET K950754MACRO SUCTION TUBE MODEL NO 10061 K934215CONTAIN-OR K915268CATHETER TWO STAGE VENOUS RETURN

View all 56 devices →

Related Devices (Code: KNW)

K260517Automatic Core Biopsy InstrumentZhejiang Curaway Medical Technology Co., Ltd.K262571EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc.K262792Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)Hologic, Inc.K260572Marrow MarxmanMedimetrix, LLC K261196Promisemed VeriEcto Automatic Biopsy NeedlesPromisemed Hangzhou Meditech Co., Ltd.K260365Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Battery CharDevicor Medical Products, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.